Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)

K
Kaustubh Limaye, MD

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase 2/3
200 participants needed
1 Location

Brief description of study

This study will test the hypothesis that patients presenting within 8 hours of onset withbral ischemia in the setting of proximal large vessel occlusions (LVO) and low baselineHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) withdiate mechanical thrombectomy (iMT) compared to initial medical management (iMM).

Detailed description of study

Currently, the vast majority of these patients do not receive immediate vessel imaging withher CT- or MR-angiography. However, acute ischemic stroke patients with low NIHSS who harbor a large vessel occlusion (LVO) later decline in 20-40% of cases, and/or have underappreciated impairments related to their relatively mild strokes. Similarly, LVOg with a transient ischemic attack (TIA) are under increased risk ofdeterioration. Such patients with apparent good collateral circulation, and hence aubstantial perfusion of the vascular territory of the occluded large artery, likely have thegain from endovascular revascularization. At the same time, this collateral perfusiony allow for more frequent recanalization, either spontaneously or by intravenous (IV) rtPA.with immediate mechanical thrombectomy (iMT) in the LVO mild stroke targetulation is limited.
This study will test the hypothesis that patients presenting within 8 hours of onset withbral ischemia in the setting of proximal large vessel occlusions (LVO) and low baselineHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) withdiate mechanical thrombectomy (iMT) compared to initial medical management (iMM).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cerebral Ischemia
  • Age: 18 Years
  • Gender: All

Inclusion Criteria:
  1. Age 18 years or older
  2. Acute ischemic stroke based on clinical diagnosis (NIHSS 0-5) and presence of anbjective neurological deficit
  3. Patients eligible for intravenous rt-PA should receive this therapy as soon asble and no later than 4.5 hours from symptom onset
  4. Proximal Intracranial Artery Occlusion on Imaging by NCCT/CTA or MRI/MRA showingusion of the intracranial ICA, M1, or an "M1-like" M2 vessel with orwithout tandem cervical lesion. Notably, "M1-like" M2 vessel occlusions are definedunctionally for the trial as following:
    1. On CTA: Occlusion of both branches after MCA division (both M2s occluded) orusion of the larger diameter M2 branch . In case of trifurcations, either thewo largest M2 branches are occluded or the occluded M2 has a larger diameterhan the combined diameter of the two other M2s . Notably, the M2 origins aredefined by the first branching point in the MCA other than the anterior temporaly rather than by anatomic landmarks (e.g., horizontal versus insular).
      or
    2. If mCTA or CTP performed (optional): a M2 occlusion which supplies a largehe MCA territory by evidence of either:
    3. The bulk (>2/3) of the MCA territory has evidence of delayed washout on multiphaseCT or ii. Perfusion imaging shows a hypoperfusion lesion volume involving agnificant proportion of the MCA territory defined as Tmax >4 sec lesion of ≥100 mL
  5. Baseline Infarct Core of either:
    1. Baseline ASPECTS ≥6 on non-contrast CT (NCCT), or
    2. Baseline Infarct Core Volume of < 70cc on either CTP (Volume of rCBF <30%) or DWIquantitative software tools are available (neither test is mandatory forudy)
Exclusion Criteria:
  1. NIHSS ≥6
  2. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH)
  3. Any imaging findings suggestive of futile recanalization in the judgment of the localvestigator
  4. High degree of suspicion of intracranial arterial disease (ICAD), such as evidence ofultifocal ICAD
  5. Premorbid disability (mRS ≥3)
  6. Inability to randomize within 8 hours of last known well
  7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
  8. Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol)
  9. Known coagulation disorders as defined as platelet count <100,000/uL
  10. Known renal failure as defined as serum creatinine levels > 3.0 mg/dL
  11. Presumed septic embolus or suspicion of bacterial endocarditis
  12. Any other condition that, in the opinion of the investigator, precludes andovascular procedure or poses a significant hazard to the subject if an endovasculardure was performed.
  13. Participation in another investigational treatment study in the previous 30 days
  14. Intubation and mechanical ventilation prior to study enrollment is medically indicated
  15. History of drug or alcohol use or dependence that, in the opinion of the sitevestigator, would interfere with adherence to study requirements
  16. Site investigator does not have equipoise towards the ideal treatment concept(thrombectomy vs. best medical management)
  17. Known pregnancy
  18. Prisoner or incarceration
  19. Known acute symptomatic COVID-19 infection

Updated on 01 Aug 2024. Study ID: IRB00107210
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